Certified Quality Manager (CQM) Medical Devices
The Certified Quality Manager Medical Devices is a 44-hour training program for three ON DEMAND e-courses. ISO 13485:2016 Lead Auditor, ISO 14971:2019 Medical Device Risk Management Requirements, and FDA 21 CFR 820 cGMP Requirements. 4.4 CEUs.
GMP-Medical - Training Bundle
The Medical Device FDA cGMP training program includes four ON DEMAND e-courses including FDA cGMP Requirements, Good Documentation Practice, Failure Mode and Effects Analysis, and FDA 21 CFR Part 11 Electronic Signatures. 1.1 CEUs.
FDA 21 CFR 820 cGMP Requirements
This ON DEMAND 6-hour e-course teaches the Quality System Regulations (QSR) and Current Good Manufacturing Practices (cGMP) required by the FDA for Medical Devices and includes a certified training Certificate of Competence. 0.6 CEUs.(6) 4.7 average rating
FDA 21 CFR 820 cGMP | 2022 Overview
This ON DEMAND 1-hour e-course is an annual GMP Overview of the Quality System Regulations (QSR) and FDA cGMP requirements for Medical Devices. Includes a certified training Certificate of Competence. 0.1 CEUs.(2) 5.0 average rating
FDA 21 CFR Part 11 Electronic Signatures-Requirements
This ON DEMAND 1-hour e-course teaches a brief overview of the key concepts and major requirements of the FDA Part 11 Electronic Records and Signatures and includes certified training Certificate of Competence. 0.1 CEUs.(1) 5.0 average rating
Validation - Training Bundle
The ISO Validation training program includes four ON DEMAND e-courses including Process Validation, Software Validation, Sampling for Validation, and Measurement System Analysis. 1.2 CEUs.